Navigation Links
AEterna Zentaris Completes Patient Recruitment for Second Efficacy Trial of its Phase 3 Program with Cetrorelix in Benign Prostatic Hyperplasia
Date:10/1/2008

H

The first multi-center efficacy study for which patient recruitment was completed in April 2008, is currently being conducted primarily in the United States and Canada, with additional sites in Europe and involves approximately 600 patients under the supervision of lead investigator, Herbert Lepor, MD, Professor at NY University School of Medicine, New York. Patients enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS). Patients are then randomly allocated to cetrorelix or placebo in a double-blind fashion. Patients are administered cetrorelix by intra-muscular (IM) injection at Week 0, 2, 26 and 28 and are followed up to Week 52. Then, in an open-label extension, patients receive cetrorelix by IM injection at Week 52, 54, 78 and 80 and are followed up to Week 90.

The second multi-center Phase 3 efficacy study for which patient recruitment completion was announced today, involves approximately 400 patients, mainly in Europe. Patients in this randomized placebo-controlled study with open-label extension, receive cetrorelix according to similar dosing regimens used in the first study.

The primary endpoint for both North American and European efficacy studies is absolute change in IPSS between baseline and Week 52. Other efficacy endpoints include additional measures of BPH symptom progression and the need for BPH-related surgery. Safety endpoints include changes in sexual function. Other important endpoints include plasma changes in levels of testosterone, and assessment of other adverse events.

The third study in the Phase 3 program, a multi-center safety study, for which patient recruitment started in May 2008, is an ongoing open-label, single-armed study involving approximately 500 patients in both North America and Europe.

About Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (BPH) is one of the most
'/>"/>

SOURCE AETERNA ZENTARIS INC.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. AEterna Zentaris to Present at BioContact Quebec on October 2, 2008
2. AEterna Zentaris to Present at Upcoming CIBC World Markets 7th Annual Eastern Investor Conference
3. AEterna Zentaris Reports Second Quarter 2008 Financial and Operating Results
4. AEterna Zentaris Announces Appointment of Prof. Jurgen Engel, Ph.D. as New President and CEO
5. AEterna Zentaris to Announce Second Quarter 2008 Financial and Operating Results on August 12, 2008
6. AEterna Zentaris Sells Quebec City Building for $7.1 million
7. AEterna Zentaris to Present at Upcoming Rodman & Renshaw Global Healthcare Conference and AUA Annual Meeting
8. AEterna Zentaris: Article on Phase 2 Trial with Cetrorelix in BPH to be Published in European Urology Journal
9. AEterna Zentaris Reports First Quarter 2008 Financial and Operating Results
10. AEterna Zentaris to Announce First Quarter 2008 Financial and Operating Results and Hold Annual Shareholder Meeting on May 7, 2008
11. AEterna Zentaris: Lead Investigator for Cetrorelix Trials in BPH Wins Best Poster Presentation Award at European Association of Urology Meeting in Milan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/13/2014)... The DNA Microarray market market was valued ... to grow at a CAGR of 15.2% from ... of the DNA Microarray for an in-depth analysis ... of various tables and figures. , http://www.micromarketmonitor.com/market-report/dna-microarray-reports-5177428198.html ... of instrument, consumables, and services, where the consumables ...
(Date:12/13/2014)... 13, 2014 The “Global Synthetic ... market drivers, threats, opportunities, and challenges. , The ... major players, namely, Thermo Fisher Scientific, Inc. (U.S.), ... players jointly accounted for approximately ~65% of the ... Full Copy for This Report @ http://www.marketsandmarkets.com/Market-Reports/synthetic-biology-market-889.html ...
(Date:12/13/2014)... 13, 2014 QuickSTAT is making significant ... Cold Chain capabilities, and is delighted to announce the ... to serve Life Science clients in the region. , ... controlled-ambient warehouse, will provide 24/7 transportation and logistics services, ... drugs, patient-clinical specimens, API, following IATA rules and EU ...
(Date:12/13/2014)... , Dec. 11, 2014 Research and Markets ... addition of the "Glucose Sensors: the Next ... http://photos.prnewswire.com/prnh/20130307/600769 The ... designs is giving hope for a better future ... monitors that can measure glucose levels accurately and ...
Breaking Biology Technology:DNA Microarray Market Is Expected to Grow at a CAGR of 15.2% from 2014 to 2019 - A Report by MicroMarket Monitor 2DNA Microarray Market Is Expected to Grow at a CAGR of 15.2% from 2014 to 2019 - A Report by MicroMarket Monitor 3DNA Microarray Market Is Expected to Grow at a CAGR of 15.2% from 2014 to 2019 - A Report by MicroMarket Monitor 4Synthetic Biology Market to HIt $5.6304 Billion by 2018 - New Research Report by MarketsandMakets 2Synthetic Biology Market to HIt $5.6304 Billion by 2018 - New Research Report by MarketsandMakets 3Quick Opens Office in France to Serve Life Science Community In France and Neighboring French-Speaking Countries 2Glucose Sensors: the Next Generation 2Glucose Sensors: the Next Generation 3
... critical care clinicians, ... DURHAM, N.C., July 24 bioMerieux recently ... Thoracic Society and,Society of Hospital Medicine, that show ... are unanimous in their view that,new methods and ...
... Instrumentation Laboratory,(IL) today announced that Broadlane, Inc., ... Company with a five-year contract covering its,critical care ... counts,among its clients more than 915 acute care ... than 18,000 physician practices., The contract covers ...
... The Global Probiotics Council,(GPC), a committee established ... Ltd., announced the two awardees who will receive ... today. The program was,created to identify young rising ... of probiotics and gut microbiota research in the ...
Cached Biology Technology:U.S. Clinicians Indicate a Strong Need for New Tools to Combat Sepsis 2U.S. Clinicians Indicate a Strong Need for New Tools to Combat Sepsis 3Instrumentation Laboratory Announces Contract for Multi-Parameter Testing Products with Broadlane 2Global Probiotics Council Announces First Awardees for New Young Investigator Grant for Probiotics Research 2Global Probiotics Council Announces First Awardees for New Young Investigator Grant for Probiotics Research 3Global Probiotics Council Announces First Awardees for New Young Investigator Grant for Probiotics Research 4
(Date:11/18/2014)... Nov. 18, 2014  The Secure Identity & ... today jointly announce the formation of The Airport ... its Identity and Biometric Entry and Exit ... received official support from BORDERPOL, the international non-profit ... and provide expertise regarding border security, traveler and ...
(Date:11/18/2014)... 18, 2014   EyeLock Inc. , a ... MorphoTrust USA (Safran), a leading U.S. ... a strategic partnership to offer comprehensive biometric identity ... (MVA), airport screening and financial services markets. ... serves consumers through a nationwide network of 1,100 ...
(Date:11/11/2014)... CHICAGO , Nov. 11, 2014  Forensicon, Inc., ... eDiscovery firm, is pleased to announce the promotion of ... to Director of Digital Forensics. In Schiff,s new role ... out the team of digital forensics examiners and provide ... Photo - http://photos.prnewswire.com/prnh/20141110/157719 ...
Breaking Biology News(10 mins):Identity Management, Document Authentication and Biometric Companies Form "The Airport Entry and Exit Working Group", Releasing the Framework to Help Guide the Department of Homeland Security and Congress Towards Solutions 2Identity Management, Document Authentication and Biometric Companies Form "The Airport Entry and Exit Working Group", Releasing the Framework to Help Guide the Department of Homeland Security and Congress Towards Solutions 3EyeLock, MorphoTrust Form Strategic Partnership to Pursue Commercial Enterprise Deployments 2EyeLock, MorphoTrust Form Strategic Partnership to Pursue Commercial Enterprise Deployments 3Yaniv Schiff Promoted to Director of Digital Forensics at Forensicon, Inc. 2
... A new plant that buries its seeds, the first in ... Brazil, by an international team of scientists. The new ... and rare characteristic that gives it its name. After fruits ... with seeds on the ground and sometimes burying them in ...
... Studying the complexities of surfacestheir textures, their ... in a broad range of fields, including anthropology, ... The 1st Surface Metrology Seminar for the Americas, ... Oct. 24-26, 2011, will bring together renowned experts ...
... ecosystems, a key idea has resonated for more than ... over time. Now a new book examines the impact ... years since H. Ronald Pulliam, former president of the ... Ecology at the University of Georgia, published a now ...
Cached Biology News:Amateur botanists discover a genuflecting plant in Brazil 2Amateur botanists discover a genuflecting plant in Brazil 3Seminar to explore advanced tools for unlocking treasures that lie right at the surface 2New book explores the evolution of a key scientific idea 2
... biomarker discovery projects require screening through ... distinguish clinically relevant data from normal ... Manager is now available to help ... and data flood inherent to biomarker ...
This free-standing laminar flow hood provides a vertical flow of HEPA-filtered air to create a clean processing area. It includes a fluorescent light and motorized sliding shield. Options include wor...
This modular laminar flow hood forces air through a 99.99% efficient HEPA filter to create a clean processing area. Configurations are available with vertical or horizontal flow; options include a wo...
... provider of X-ray crystallography services for ... services to its pharmaceutical and biotechnology ... of drug-like fragments to the active ... allowing scientists to develop novel, high-affinity ...
Biology Products: